Low locoregional recurrence rate among node-negative breast cancer patients with tumors 5 cm or larger treated by mastectomy, with or without adjuvant systemic therapy and without radiotherapy: Results from five National Surgical Adjuvant Breast and Bowel Project randomized clinical trials
chemotherapy; irradiation; Oncology; postmastectomy radiotherapy; postoperative radiotherapy; premenopausal women; radiation-therapy; receptor-positive tumors; risk-factors; sequential methotrexate; tamoxifen
Purpose Lymph node (LN)-negative breast cancer tumors >= 5 cm occur infrequently, and their optimal management is not well defined. In this study, we assess patterns of locoregional failure (LRF) in LN-negative patients who underwent mastectomy, either with or without adjuvant chemotherapy or hormonal therapy and without postmastectomy radiation therapy (PMRT). Patients and Methods Of 8,878 breast cancer patients enrolled onto National Surgical Adjuvant Breast and Bowel Project B-13, B-14, B-19, B-20, and B-23 node-negative trials, 313 had tumors that were 5 cm or larger (median, 5.5 cm; range, 5.0 to 15.5 cm) at pathology and were treated by mastectomy. Median follow-up time was 15.1 years. Therapy included adjuvant chemotherapy in 34.2% of patients; tamoxifen in 21.1%; chemotherapy plus tamoxifen in 19.2%; and no systemic therapy in 25.5%. Results Twenty-eight patients experienced LRF. The overall 10-year cumulative incidences of isolated LRF, LRF with and without distant failure (DF) and DF alone as first event were 7.1%, 10.0%, and 23.6%, respectively. cumulative incidences for isolated LRF as first event for patients with tumors of 5 cm or more than 5 cm were 7.0% and 7.2%, respectively (P=.9). For patients who underwent no systemic treatment, chemotherapy alone, tamoxifen alone, of chemotherapy plus tamoxifen, the incidences were 12.6%, 5.6%, 4.6%, and 5.3%, respectively (P=.2). The majority of failures occurred on the chest wall (24 of 28 patients). Multivariate analysis did not identify significant prognostic factors for LRF. Conclusion In patients with LN-negative tumors >= 5 cm who are treated by mastectomy with or without adjuvant systemic therapy and no PMRT, LRF as first event remains low. PMRT should not be routinely used for these patients.
Taghian A G; Jeong J H; Mamounas E P; Parda D S; Deutsch M; Costantino J P; Wolmark N
Journal of Clinical Oncology
2006
2006-08
Journal Article
<a href="http://doi.org/10.1200/jco.2006.06.9054" target="_blank" rel="noreferrer noopener">10.1200/jco.2006.06.9054</a>
Preoperative chemotherapy: Updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27
cancer patients; chemotherapy; competing risk; conservative treatment; estrogen-receptor status; expressing estrogen; induction; multimodal; neoadjuvant chemotherapy; Oncology; radiation-therapy; treatment; tumor response
Purpose National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-18 was designed to determine whether four cycles of doxorubicin and cyclophosphamide (AC) administered preoperatively improved breast cancer disease-free survival (DFS) and overall survival (OS) compared with AC administered postoperatively. Protocol B-27 was designed to determine the effect of adding docetaxel (T) to preoperative AC on tumor response rates, DFS, and OS. Patients and Methods Analyses were limited to eligible patients. In B-18, 751 patients were assigned to receive preoperative AC, and 742 patients were assigned to receive postoperative AC. In B-27, 784 patients were assigned to receive preoperative AC followed by surgery, 783 patients were assigned to AC followed by T and surgery, and 777 patients were assigned to AC followed by surgery and then T. Results Results from B-18 show no statistically significant differences in DFS and OS between the two groups. However, there were trends in favor of preoperative chemotherapy for DFS and OS in women less than 50 years old (hazard ratio [HR] = 0.85, P = .09 for DFS; HR = 0.81, P = .06 for OS). DFS conditional on being event free for 5 years also demonstrated a strong trend in favor of the preoperative group (HR = 0.81, P = .053). Protocol B-27 results demonstrated that the addition of T to AC did not significantly impact DFS or OS. Preoperative T added to AC significantly increased the proportion of patients having pathologic complete responses (pCRs) compared with preoperative AC alone (26% v 13%, respectively; P < .0001). In both studies, patients who achieved a pCR continue to have significantly superior DFS and OS outcomes compared with patients who did not. Conclusion B-18 and B-27 demonstrate that preoperative therapy is equivalent to adjuvant therapy. B-27 also showed that the addition of preoperative taxanes to AC improves response.
Rastogi P; Anderson S J; Bear H D; Geyer C E; Kahlenberg M S; Robidoux A; Margolese R G; Hoehn J L; Vogel V G; Dakhil S R; Tamkus D; King K M; Pajon E R; Wright M J; Robert J; Paik S; Mamounas E P; Wolmark N
Journal of Clinical Oncology
2008
2008-02
Journal Article
<a href="http://doi.org/10.1200/jco.2007.15.0235" target="_blank" rel="noreferrer noopener">10.1200/jco.2007.15.0235</a>
Prognosis after ipsilateral breast tumor recurrence and locoregional recurrences in five national surgical adjuvant breast and bowel project node-positive adjuvant breast cancer trials
20-year follow-up; conservative surgery; conserving therapy; doxorubicin-cyclophosphamide; european organization; local recurrence; Oncology; radiation-therapy; randomized-trial; risk-factors; stage-i
Purpose Locoregional failure after breast-conserving surgery is associated with increased risk of distant disease and death. The magnitude of this risk in patients receiving chemotherapy has not been adequately characterized. Patients and Methods Our study population included 2,669 women randomly assigned onto five National Surgical Adjuvant Breast and Bowel Project node-positive protocols (B-15, B-16, B-18, B-22, and B-25), who were treated with lumpectomy, whole-breast irradiation, and adjuvant systemic therapy. Cumulative incidences of ipsilateral breast tumor recurrence (IBTR) and other locoregional recurrence (oLRR) were calculated. Kaplan-Meier curves were used to estimate distant-disease-free survival (DDFS) and overall survival (OS) after IBTR or oLRR. Cox models were used to model survival using clinical and pathologic factors jointly with IBTR or oLRR as time-varying predictors. Results Four hundred twenty-four patients (15.9%) experienced locoregional failure; 259 (9.7%) experienced IBTR, and 165 (6.2%) experienced oLRR. The 10-year cumulative incidence of IBTR and oLRR was 8.7% and 6.0%, respectively. Most locoregional failures occurred within 5 years (62.2% for IBTR and 80.6% for oLRR). Age, tumor size, and estrogen receptor status were significantly associated with IBTR. Nodal status and estrogen and progesterone receptor status were significantly associated with oLRR. The 5-year DDFS rates after IBTR and oLRR were 51.4% and 18.8%, respectively. The 5-year OS rates after IBTR and oLRR were 59.9% and 24.1%, respectively. Hazard ratios for mortality associated with IBTR and oLRR were 2.58 (95% CI, 2.11 to 3.15) and 5.85 (95% CI, 4.80 to 7.13), respectively. Conclusion Node-positive breast cancer patients who developed IBTR or oLRR had significantly poorer prognoses than patients who did not experience these events.
Wapnir I L; Anderson S J; Mamounas E P; Geyer C E; Jeong J H; Tan-Chiu E; Fisher B; Wolmark N
Journal of Clinical Oncology
2006
2006-05
Journal Article
<a href="http://doi.org/10.1200/jco.2005.04.3273" target="_blank" rel="noreferrer noopener">10.1200/jco.2005.04.3273</a>
Updated results of the combined analysis of NCCTG N9831 and NSABP B-31 adjuvant chemotherapy with/without trastuzumab in patients with HER2-positive breast cancer
Oncology
Perez E A; Romond E H; Suman V J; Jeong J; Davidson N E; Geyer C E; Martino S; Mamounas E P; Kauffman P A; Wolmark N
Journal of Clinical Oncology
2007
2007-06
Journal Article
<a href="http://doi.org/10.1200/jco.2006.09.3849" target="_blank" rel="noreferrer noopener">10.1200/jco.2006.09.3849</a>